The proprietary,
product-driven A-fects™ lipid technology is based on artificial envelopes
created by lipids providing a significant advancement for transmucosal
delivery.

A-fects™ are a
new type of liposomes containing membrane spanning lipids derived from
archaebacteria. These new liposomes are superior to conventional liposomes in
many respects. As archaebacteria thrive in extreme environments e.g.
extremely high or low temperatures, highly acidic or basic milieu,
archae-lipids are chemically stable over a much greater range of temperatures
and pH conditions compared to conventional lipids. This presents a
significant advancement for the delivery of therapeutics, allowing for more
varied routes of administration, especially the oral route.

Bernina has
developed a variety of archae-lipids, uncharged as well as positively or
negatively charged, that accomplish the passage through the GI-tract and
facilitate the uptake of orally administered peptides. A set of modified
lipids mediating target specificity complements the highly variable A-fects™
toolbox.

Artificial
Envelopes

The Artificial
Envelope™ delivery technology combines conventional, pharmaceutically
accepted - off the shelf - lipid components with the A-fects™ technology to
create a new generation of drug delivery systems.

Toxicity

Extensive
toxicity studies have been carried out in vitro and in vivo (rodents). Even
with intravenous administration of high doses, no acute toxicity (NOE level
1000 mg/kg), no genotoxicity, no immunotoxicity and no CNS-toxicity was observed.
A moderate repeated dose toxicity has been observed at very high i.v. doses
(NOE level 100 mg/kg*days).

Production
process

The production
process is standardized and reproducible. At this point the preformulation of
a new compound/peptide can be accomplished in a matter of weeks allowing for
the application of the A-fects™ technology for a variety of new projects.

Intellectual
Property Status

Bernina
Plus owns a set of issued patents as well as pending applications that
cover the A-fectsTM technology. The IP applies to the use of synthetic lipids
as well as lipids derived from nature.

The IP-Portfolio
comprises 3 granted patents (2 US + 1 DE) and 14 patent applications,
covering several variants of lipids, formulations and methods for synthesis
and purification of lipids. The portfolio consists of both own and
in-licensed property rights.